During the packaging, transportation and production process, active ingredients may chemically react with the packaging materials. The interaction between the packaging materials used and the drugs will also lead the reduction in the effectiveness and stability of the drugs, which may further threaten the health of patients. The FDA pointed out that these interactions must not have adverse effects on the applicability of drugs and packaging materials, and required drug manufacturers to evaluate the compatibility of drugs and packaging materials to ensure the drug quality. The FDA provides a number of regulatory publications and guidance for generic drug manufacturers to conduct packaging material compatibility studies as part of the generic consistency evaluation. Alfa Chemistry provides packaging compatibility testing services to analyze the consistency of packaging systems in terms of compatibility with dosage forms and drugs based on the guidance of USP 39.
Our packaging compatibility testing platform is available for the analysis of:
- Compatibility of injections and plastic packaging materials
- Compatibility of injections and pharmaceutical glass containers
- Elastomer seal compatibility
Application of the Packaging Compatibility Testing
- Assess potential safety impacts of materials with a degree of certainty that is appropriate for early product development and/or manufacturing
- Predict the properties of extractables in the systems using this packaging material
- Identify and justify the use (or non-use) of a particular packaging materials
Packaging Compatibility Testing Procedure
Alfa Chemistry conducts pharmaceutical equivalence evaluation of packaging material compatibility based on the physical and chemical properties of packaging material, manufacturing process and formulation of generic drugs.
Method development
- Identification and analysis of the components of packaging material
- Analysis of the potential interaction between packaging material and drug products
- Analysis of the manufacturing process of pharmaceuticals
Compatibility test
We provide stability testing under different testing conditions such as stored at elevated stress conditions (e.g., high temperatures and/or humidity).
Safety assessment
We perform the extractables and leachables testing, and provide a preliminary risk assessment of extractables:
- Provide migration testing and adsorption testing on different types of packaging materials
- Determination and calculation of the adsorption capacity of the packaging material system on the raw materials and excipients
- Determination of the leachables from packaging materials in contact with drugs
- Safety assessment of migration/leaching levels of packaging materials according to FDA, ICH, US Environmental Protection Agency (EPA) database and other standards
Toxicity assessment
Detection of the potential toxicity of packaging materials
Analysis of test results
At Alfa Chemistry, the results of compatibility testing are comprehensively analyzed to help you determine whether the packaging material is suitable for the proposed drug product.
Our Advantages
- Our industrial experts provide a scientific and reasonable packaging material compatibility test solution to help you select suitable packaging materials
- Advanced instrument platform and database to support for various analysis requirement: thermal analysis, infrared analysis, and physical and chemical analysis.
- Test reports that meet industry requirements for quality, safety, performance, and regulations
